FDA signaled during an advisory committee on Orexigen's weight-loss drug Contrave that it could be ready to revise its obesity drug draft guidance, particularly with regard to cardiovascular goals, but stressed that for now, the drugs under review are to be judged by standards articulated in the draft document.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
PTC Therapeutics is continuing to supply its Duchenne muscular dystrophy treatment, Translarna, in some European markets, despite EU revocation of the drug’s conditional marketing authorization earlier this year.
The UK Health Research Authority’s latest three-year strategy sets ambitious targets to make research more transparent. One World Health Organization official believes the authority can go further by setting equally high standards for the timely reporting of clinical trial results.
Other authorities are expected to mirror the European Medicines Agency’s decision to lift the temporary restriction it placed on using Valneva’s chikungunya vaccine in people aged 65 years and older.
